(561 days)
- The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document describes the performance of "CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)" against established standards for patient examination gloves.
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D 3578-91) | Reported Device Performance (CHEMO PLUS Powder Free Blue Latex Examination Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | ||
| Size XS | - | - |
| Size S | min 230 | 292 |
| Size M | min 230 | 304 |
| Size L | min 230 | 308 |
| Size XL | - | - |
| 3. Palm width (mm) | ||
| Size XS | - | - |
| Size S | 80 ± 10 | 83 |
| Size M | 95 ± 10 | 95 |
| Size L | 111 ± 10 | 106 |
| Size XL | - | - |
| 4. Thickness (mm) | ||
| Finger | min 0.08 | 0.46 |
| Palm | min 0.08 | 0.27 |
| 5. Physical Properties: Before Ageing | ||
| Tensile Strength (MPa) | min 21 | 30.78 |
| Ultimate Elongation (%) | min 700 | 839 |
| 5. Physical Properties: After Ageing | ||
| Tensile Strength (MPa) | min 16 | 27.41 |
| Ultimate Elongation (%) | min 500 | 845 |
| 6. Powder Content | - | below 2 mg / glove |
| 7. Moisture Content | - | max 0.8% / glove |
| 8. Protein Content | - | below 50 microgram / gram |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for watertightness, length, etc.). It generally refers to "performance test data."
The data provenance is from WEMBLEY RUBBER PRODUCTS (M) SDN BHD in Malaysia. The study is a non-clinical performance test of the manufactured device. It is a retrospective evaluation of the product's characteristics against a standard, not a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" (acceptance criteria) for most tests is the ASTM D 3578-91 standard itself. For the "Watertight (1000 ml)" test, the acceptance criteria is "S-4, AQL 4.0," which is a widely accepted standard in glove manufacturing. The protein content claim is a specific assertion about the glove's composition. These are objective measures against established technical standards, not subjective expert assessments.
4. Adjudication method for the test set
This information is not applicable as the tests are objective measurements against published standards (ASTM D 3578-91 and FDA 1000 ml watertight test). There is no reference to human experts adjudicating results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document describes the performance characteristics of medical examination gloves, not an AI or imaging device that would involve human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes the physical and chemical performance of medical examination gloves, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used primarily consists of established technical standards and specifications:
- ASTM D 3578-91: This is a comprehensive standard for rubber examination gloves.
- FDA 1000 ml watertight test: Another specific test for glove integrity.
- Protein content labeling claim: A manufacturer-defined specification for the protein level, which is then verified using a standard method (ASTM D5712).
These are objective, quantifiable criteria.
8. The sample size for the training set
This is not applicable. This is not a machine learning model, so there is no training set. The data presented is for the performance evaluation of a manufactured product.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a machine learning model. The "ground truth" for the device's performance evaluation is established by the aforementioned ASTM and FDA specifications.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.